Hearing Global Harmonization

Tuesday, September 28, 2010

In today’s global marketplace, many medical device manufacturers are planning on selling their products worldwide, or at least in major geographic and economic hubs. However, getting a handle on the large number of obscure and often conflicting national/regional medical device regulations and quality system requirements can be a time-consuming and error-prone task. One key resource to help medical device manufacturers better understand international requirements is the Global Harmonization Task Force (GHTF). Today, we will provide a brief summary of the GHTF and point out some related resources.

The GHTF is a voluntary group, started in 1992, with representation from the regulatory authorities and the medical device industry from across the globe. The five founding members include the European Union, United States, Canada, Australia and Japan. Membership was expanded in 2006 to include three Liaison Body members: Asian Harmonization Working Party (AHWP), International Organization for Standardization (ISO), and the International Electrotechnical Commission (IEC). Needless to say, this expansive set of members, which includes the US FDA, represents a very comprehensive group of world-wide regulatory authorities, and provides the forum for truly effective global regulatory harmonization.

The GHTF website provides the organization's statement of purpose:

"The purpose of the GHTF is to encourage convergence in regulatory practices related to ensuring the safety, effectiveness / performance and quality of medical devices, promoting technological innovation and facilitating international trade. The primary way in which this purpose is accomplished is via the publication and dissemination of harmonized documents on basic regulatory practices. These documents, which are developed by five different GHTF Study Groups, provide a model for the regulation of medical devices that can then be adopted/implemented by national regulatory authorities."

There are five chartered GHTF study groups, each of which is actively engaged in developing and publishing important (and useful) harmonized documents which are available, at no charge, to the world-wide medical device industry. The five GHTF study groups are:

Study Group 1- PreMarket Evaluation
Study Group 2: Post-Market Surveillance/Vigilance
Study Group 3: Quality Systems
Study Group 4: Auditing
Study Group 5: Clinical Safety/Performance

An example of a recent useful publication from the GHTF is Definitions of the Terms Manufacturer, Authorized Representative, Distributor and Importer (PDF) from Study Group 1. These are key terms that US medical device manufacturers might encounter when attempting to expand their market world-wide, and this GHTF guidance is a useful reference.

A visit to the GHTF website will provide access to many more GHTF publications that have been developed to assist medical device manufacturers in understanding and implementing world-wide regulatory and quality system requirements.

Stay tuned for next week as we highlight additional GHTF publications useful to IVD manufacturers. 



Tags: EU, Ex-US, FDA, GHTF, Quality Systems

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